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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Recalls

All product recalls associated with The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories.

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Recall Summary

Total Recalls

1000

Past Year

206

Class I (Serious)

410

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 241–260 of 3552 recalls

Duloxetine Capsules (Harvard Drug Group) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Class IIModerate

FDAJan 13, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Allura Xper FD20 (Philips) – Patient Fall Risk (2025)

Possibility of the patient falling from the table related to the mattress used on the patient table.

Moderate

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

AlluraXperFD20/15 (Philips) – Safety Issue (2025)

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

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High

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 M12 (Philips) – Safety Issue (2025)

High

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Nobel Biocare N1 TiUltra (Nobel) – Packaging Defect (2025)

Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

High

FDAJan 10, 2025Nationwide• Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden

MSOT Acuity Echo (Ithera) – Safety Instruction (2025)

The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

Moderate

FDAJan 8, 2025Nationwide• Ithera Medical Gmbh Zielstattstr. 13 Munich Germany

The OG Bar (The Granola Bar) – Undeclared Milk/Soy (2024)

Undeclared Milk

Product contains undeclared milk and soy.

Class IIModerate

FDADec 31, 2024CT, NY• The Granola Bar

CryoSolutions Cartridges (New Medical Technologies) – Valve Premature Opening (2024)

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

Moderate

FDADec 19, 2024Nationwide• New Medical Technologies Gmbh Wankdorffeldstrasse

Ketamine Injection 50mg (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

Phenylephrine Injection (Hikma) – tamper seal issue (2024)

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Class IIModerate

FDADec 19, 2024Nationwide• Hikma Injectables USA Inc

Calibrate CCX Interbody System (Alphatec) – Implant Collapse Risk (2024)

Complaints have been received regarding post-operative implant collapse.

Moderate

FDADec 15, 2024Nationwide• Alphatec Spine, Inc. 1950 Camino Vida Roble

C240 Battery Chargers (HTRC) - Fire Risk (2024)

Fire/Burn Risk

This recall involves HTRC C240 battery chargers sold for charging lithium-ion batteries. The defective chargers are black with two blue screens, numbered 1 and 2, and the model identifier "C240 DUO" printed between the screens. The brand name "HTRC" is printed at the bottom left corner.

Very High

CPSCDec 12, 2024Nationwide• Shenzhen Haitan Technology Co. Ltd., d/b/a HTRC, of China

Nhan Sam Tuyet Lien Capsules (Buy-Herbal) – Undeclared Medications (2024)

Undeclared Allergen

Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine

Class IHigh

FDADec 12, 2024Nationwide• Buy-Herbal

Cucumbers (Wholesale Produce) - Salmonella Risk (2024)

Salmonella

Cucumbers may be contaminated with Salmonella.

Class IHigh

FDADec 12, 2024IL, IA, KS +6 more• WHOLESALE PRODUCE SUPPLY LLC DBA

Idylla Instrument (Biocartis) – False-Positive MSI-H Results (2024)

False-positive MSI-H results generated by the Idylla MSI Test.

Moderate

FDADec 10, 2024AL, CA, NJ +2 more• Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium

Cascade Raw Cheddar (Heber Valley) – E. coli risk (2024)

E. coli

The Cascade Raw Cheddar Cheese was recalled due to Shiga toxin-producing E. coli (STEC) and elevated generic E.coli in finished product testing results.

Class IHigh

FDADec 6, 2024MT, NV, UT +1 more• Heber Valley Artisan Cheese, LLC.

Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 20 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany

Surgical Sheath 18 Fr (Trokamed) – Inflow Speed Risk (2024)

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

High

FDANov 27, 2024IN, PA• Trokamed GmbH Kleine Breite 17 Geisingen Germany